ID

31625

Descrição

Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00895466

Link

https://clinicaltrials.gov/show/NCT00895466

Palavras-chave

Versões (1)
  1. 14/09/2018 14/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00895466

Inglês

Eligibility Prostate Cancer NCT00895466

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathological confirmed prostatic adenocarcinoma, clinical stage (c) ct1-3, cn0-1/x, cm0
Descrição

Adenocarcinoma of prostate TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
baseline testosterone levels of > 4 nmol/l
Descrição

Testosterone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0523912
baseline psa level of > 10 microg/l
Descrição

Prostate specific antigen measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201544
eligible for hormone therapy
Descrição

Eligibility Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0279025
willingness to comply with the protocol conditions and procedures
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
willing and able to give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical evidence of distant metastases
Descrição

Distant metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269798
previous hormonal therapy administered specifically for prostatic carcinoma
Descrição

Prior Hormone Therapy Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0600139
development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
Descrição

Invasive cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
Descrição

Primary immunodeficiency | Secondary immunodeficiency | Immunosuppression | Adrenal Cortex Hormones | Immunosuppressive Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3]
C4048329
UMLS CUI [4]
C0001617
UMLS CUI [5]
C0021081
concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
Descrição

Immunologic Adjuvants | Testosterone Supplement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001551
UMLS CUI [2,1]
C0039601
UMLS CUI [2,2]
C2348609
concomitant radiotherapy for prostate cancer
Descrição

Therapeutic radiology procedure Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0600139
presence of bacterial prostatitis causing a psa increase during the 8 weeks preceding study inclusion
Descrição

Bacterial prostatitis Causing Raised prostate specific antigen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0748023
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0178415
simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
bmi > 30 kg/square meter
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
previous serious reaction to a vaccine such as angioedema or anaphylaxis
Descrição

Reaction Serious Vaccines | Angioedema | Anaphylaxis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0443286
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0002994
UMLS CUI [3]
C0002792
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Similar models

Eligibility Prostate Cancer NCT00895466

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging
Item
pathological confirmed prostatic adenocarcinoma, clinical stage (c) ct1-3, cn0-1/x, cm0
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Testosterone measurement
Item
baseline testosterone levels of > 4 nmol/l
boolean
C0523912 (UMLS CUI [1])
Prostate specific antigen measurement
Item
baseline psa level of > 10 microg/l
boolean
C0201544 (UMLS CUI [1])
Eligibility Hormone Therapy
Item
eligible for hormone therapy
boolean
C1548635 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Protocol Compliance
Item
willingness to comply with the protocol conditions and procedures
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
clinical evidence of distant metastases
boolean
C1269798 (UMLS CUI [1])
Prior Hormone Therapy Prostate carcinoma
Item
previous hormonal therapy administered specifically for prostatic carcinoma
boolean
C1514460 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Invasive cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Primary immunodeficiency | Secondary immunodeficiency | Immunosuppression | Adrenal Cortex Hormones | Immunosuppressive Agents
Item
primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C4048329 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
Immunologic Adjuvants | Testosterone Supplement
Item
concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
boolean
C0001551 (UMLS CUI [1])
C0039601 (UMLS CUI [2,1])
C2348609 (UMLS CUI [2,2])
Therapeutic radiology procedure Prostate carcinoma
Item
concomitant radiotherapy for prostate cancer
boolean
C1522449 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Bacterial prostatitis Causing Raised prostate specific antigen
Item
presence of bacterial prostatitis causing a psa increase during the 8 weeks preceding study inclusion
boolean
C0748023 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0178415 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Body mass index
Item
bmi > 30 kg/square meter
boolean
C1305855 (UMLS CUI [1])
Reaction Serious Vaccines | Angioedema | Anaphylaxis
Item
previous serious reaction to a vaccine such as angioedema or anaphylaxis
boolean
C0443286 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0002994 (UMLS CUI [2])
C0002792 (UMLS CUI [3])
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